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FDA 510(k) Application Details - K052331
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K052331
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
P O BOX 7393
MOUNTAIN VIEW, CA 94039-7393 US
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Contact
ISKRA MRAKOVIC
Other 510(k) Applications for this Contact
Regulation Number
892.1550
More FDA Info for this Regulation Number
Classification Product Code
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/26/2005
Decision Date
11/10/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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